Quality Manual ISO/TS 16949:2002

Quality Management System

CORPORATE HEADQUARTERS:

MANUFACTURING:

OPTEK Technology 1645 Wallace Drive Carrollton, TX 75006

Optron de Mexico Avenue Rio Bravo #1551 Parque Industrial Rio Bravo Cd. Juarez, Chihuahua 32700

Table of Contents
ABOUT THIS MANUAL ............................................................................................................. 5 APPROVALS:............................................................................................................................ 5 OVERVIEW OF TT ELECTRONICS / OPTEK .......................................................................... 5 SCOPE ...................................................................................................................................... 6 APPLICABLE STANDARDS...................................................................................................... 6 MANAGEMENT STRUCTURE.................................................................................................. 7 1 MANAGEMENT PROCESSES .......................................................................................... 7

1.1 Quality Management System Implementation & Maintenance....................................... 7 1.1.1 QMS General Requirements.................................................................................... 7 1.1.2 Management Commitment ...................................................................................... 9 1.1.3 Customer Focus ...................................................................................................... 9 1.1.4 Quality Policy ........................................................................................................... 9 1.1.5 Quality Management System Planning.................................................................. 10 1.1.6 Responsibility and Authority................................................................................... 10 1.1.6.1 Responsibility for quality ................................................................................. 11 1.1.6.2 Departmental responsibility for quality ............................................................ 11 1.1.6.3 Individual responsibility................................................................................... 11 1.1.7 Management Representative................................................................................. 12 1.1.7.1 Customer representative ................................................................................ 12 1.1.8 Provision of Resources .......................................................................................... 13 1.1.9 Human resources - General................................................................................... 13 1.1.9.1 Competence, awareness and training ............................................................ 13 1.1.9.2 Product design skills ....................................................................................... 13 1.1.9.3 Training........................................................................................................... 14 1.1.9.4 Training on the job.......................................................................................... 14 1.1.9.5 Employee motivation and empowerment........................................................ 14 1.1.10 Planning of Product Realization............................................................................ 14 1.1.10.1 Planning of product realization - Supplemental .............................................. 15 1.1.10.2 Acceptance criteria ......................................................................................... 15 1.1.10.3 Confidentiality ................................................................................................. 15 1.1.10.4 Change control ............................................................................................... 15 1.2 Management Review ................................................................................................... 15 1.2.1 General - Quality Management System Performance (Mgmt. Review) ................. 15

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1.2.1.1 Review Input................................................................................................... 15 1.2.1.2 Review Output ................................................................................................ 17 1.2.2 Quality Objectives................................................................................................. 17 1.2.3 Measurement Analysis & Improvement - General ................................................ 19 1.2.3.1 Identification of Statistical Tools ..................................................................... 19 1.2.3.2 Knowledge of Basic Statistical Concepts........................................................ 19 1.2.4 Customer Satisfaction........................................................................................... 19 1.2.5 Analysis and Use of Data ..................................................................................... 20 1.2.6 Continual Improvement......................................................................................... 21 1.3 Communication ............................................................................................................. 21 1.3.1 Internal Communication........................................................................................ 21 1.3.2 Customer Communication .................................................................................... 21 1.4 Internal Auditing ........................................................................................................... 22 1.4.1 Internal Audit of the Quality Management System................................................ 22 1.4.2 Internal Audit Plans............................................................................................... 22 1.4.3 Internal Auditor Qualification.................................................................................. 23 1.4.4 Manufacturing Process Audit ................................................................................. 23 1.4.5 Product Audit ......................................................................................................... 23 1.5 Corrective & Preventive Action .................................................................................... 23 1.5.1 Corrective Action ................................................................................................... 23 1.5.1.1 Problem Solving ............................................................................................. 24 1.5.1.2 Error-Proofing ................................................................................................. 24 1.5.1.3 Corrective Action Impact................................................................................. 24 1.5.1.4 Rejected Product Test / Analysis.................................................................... 24 1.5.2 Preventive Action................................................................................................... 24 2 REALIZATION PROCESSES:.......................................................................................... 25

2.1 Requirements Determination & Review ....................................................................... 25 2.1.1 Determination of requirements related to product................................................. 25 2.1.2 Review of Requirements Related to Product, Manufacturing Feasibility................ 25 2.2 Design & Development ................................................................................................ 26 2.2.1 Design and Development ...................................................................................... 26 2.2.2 Design and Development Planning........................................................................ 26 2.2.3 Multidisciplinary Approach ..................................................................................... 26 2.2.4 Design and Development Input.............................................................................. 26 2.2.5 Special Characteristics .......................................................................................... 27 2.2.6 Design and Development Output........................................................................... 27 2.2.7 Design and Development Review, Monitoring ....................................................... 27 2.2.8 Design and Development Verification.................................................................... 28 2.2.9 Design and Development Validation...................................................................... 28 2.2.10 Prototype Program................................................................................................ 28

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2.2.11 2.2.12

Product Approval Process .................................................................................... 28 Control of Design and Development Changes...................................................... 28

2.3 Purchasing.................................................................................................................... 29 2.3.1 Purchasing Process............................................................................................... 29 2.3.2 Regulatory Conformity ........................................................................................... 29 2.3.3 Supplier Quality Management System Development............................................. 29 2.3.4 Customer-Approved Sources................................................................................. 29 2.3.5 Purchasing Information.......................................................................................... 30 2.3.6 Verification of Purchased Product and Incoming Product Quality.......................... 30 2.3.7 Supplier Monitoring................................................................................................ 30 2.4 Facilities & Equipment Management............................................................................ 30 2.4.1 Infrastructure.......................................................................................................... 30 2.4.1.1 Plant, facility and equipment planning ............................................................ 31 2.4.1.2 Contingency plans .......................................................................................... 31 2.4.2 Work Environment ................................................................................................. 31 2.4.2.1 Work Environment .......................................................................................... 31 2.4.2.2 Personnel Safety to Achieve Product Quality ................................................. 31 2.4.2.3 Cleanliness of Premises ................................................................................. 32 2.4.3 Customer Property................................................................................................. 32 2.4.3.1 Customer Property ......................................................................................... 32 2.4.3.2 Customer Owned Production Tooling ............................................................. 32 2.4.4 Control of Monitoring & Measurement Devices...................................................... 32 2.4.4.1 Control of Monitoring and Measuring Devices ................................................ 32 2.4.4.2 Measurement System Analysis ...................................................................... 33 2.4.4.3 Calibration / Verification Records ................................................................... 33 2.4.4.4 Laboratory Requirements ............................................................................... 34 2.4.4.4.1 Internal Laboratory ...................................................................................... 34 2.4.4.4.2 External Laboratory ..................................................................................... 34 2.5 Company Control Specifics.......................................................................................... 34 2.5.1 Document Control.................................................................................................. 34 2.5.1.1 Control of Documents and Engineering Specifications ................................... 34 2.5.2 Records Control..................................................................................................... 35 2.5.2.1 Control and Retention of Records .................................................................. 35 2.5.3 Control of Production Provision ............................................................................. 35 2.5.3.1 Control of Production ...................................................................................... 35 2.5.3.2 Control Plan.................................................................................................... 36 2.5.3.3 Work Instructions............................................................................................ 36 2.5.3.4 Verification of job set-ups ............................................................................... 36 2.5.3.5 Preventive and Predictive Maintenance ......................................................... 36 2.5.3.6 Management of Production Tooling................................................................ 37 2.5.3.7 Production Scheduling.................................................................................... 37 2.5.3.8 Feedback of Information ................................................................................. 38 2.5.4 Validation of Processes ......................................................................................... 38

.......................1 Control of Nonconforming Product and Reworked Product ..... 41 2.. 42 APPROVALS & REVISION HISTORY............................................................. 38 2.............. 39 2...............6.9.................................... 43 APPENDIX A: ISO/TS CROSS REFERENCE TO THIS MANUAL...................................................1 Monitoring and Measurement of Product........................ 41 2...............................1 Monitoring and Measurement of Processes .........5.2 Storage and Inventory ..5...........5.........................6 Preservation...................................8...................5......... 41 2...............................7 Monitoring & Measuring of Processes ........................................................5....5.........................9 Control of Nonconforming Product.............. 39 2.......2 Monitoring and Measurement of Manufacturing Processes........... 39 2...... 44 ..................................2 Customer Waiver .................5 Identification of Traceability ...........................................5...................5.....................5................................2 Dimensional Inspection and Functional Testing ....8 Monitoring & Measuring of Product.....5..7........................5.................6..............7.........................: 4 of 46 Revision: 0 Issued: 2004/Feb/02 Quality Manual 2........8...........5...........................Page No.5.................... 38 2......................................... 40 2.... 38 2........................ 39 2. 40 2........................................................................1 Preservation of Product ..9...............................

military & Hi-Rel applications. The online version of this quality manual is available to all employees via computers. encoders. process focus. The Management Representative maintains this manual for the Quality Management System and for Optek employees’ use. 2004 Approvals: J. management by a system of processes and ultimately decisions that are based on good sound data. Avenue Rio Bravo #1551 Park Industrial Rio Bravo. Chihuahua Mexico 32700.O. & VCSEL). It is the responsibility of the Department Heads to ensure that employees are familiar with the manual’s content related to their work and responsibilities. The quality management system developed by this manual was based on & demonstrates throughout its wording good quality principles such as leadership. Cd. Texas 75006 with manufacturing facilities at Optron de Mexico. mutually beneficial supplier relationships. and that they are kept informed of any changes and updates. visible. 5-3-04 Date Overview of TT electronics / OPTEK TT electronics / OPTEK Technology. OPTEK provides sensor technologies such as optical (IR. industrial applications. OPTEK’s business activities are the design. the continual improvement of the system and the prevention of nonconformity. Rodney Bailey Mgmt. Carrollton.: 5 of 46 Revision: 0 Issued: 2004/Feb/02 Quality Manual About this Manual This manual was developed for a quality management system aimed primarily at achieving customer satisfaction by meeting customer requirements through the application of the system. manufacturing. is headquartered at 1645 Wallace Drive.5G). Updates of the manual are issued as required. customer focus. The online version is to be considered the most current and takes precedence over any printed copy. hereafter called OPTEK. magnetic (Halleffect & Magnetoresistive) and fiber optic (LED & VCSEL to 2. and sale of electronic sensors. OPTEK sensors are found in office equipment. Representative 5-3-04 Date Jerry Gallagher President / C. Effective date of this quality manual: May 3. The online version incorporates links (in blue) to other pertinent procedures.E. process maps. medical .Page No. and documents making it use easier than a printed version. involvement of the employees. Requests for changes should be submitted to the Management Representative. Juarez. continual improvement.

particular requirements for the application of ISO 9001:2000 for automotive production. OPTEK’s implemented Quality Management System. Scope This Quality Management System described hereafter complies with all the requirements of ISO/TS 16949 Revision 2002. Its purpose is: • for internal use. Texas 75006 or Optron de Mexico.: 6 of 46 Revision: 0 Issued: 2004/Feb/02 Quality Manual diagnostic equipment. . Applicable Standards The content and application of this quality manual makes reference to the following publications and documents: • • • • ISO/TS 16949:2002.fundamentals and vocabulary ISO 9001: 2000.requirements ISO 9004: 2000. ISO 9000: 2000. The scope of the Quality Management System covers the design and manufacturing of sensor systems. the manufacture of custom made piece parts and final products as well as the construction of dies and fixtures at either OPTEK’s location at 1645 Wallace Drive.Page No.guidelines for performance improvement For this quality manual. Quality Management Systems . to facilitate the implementation and maintenance of the Quality Management System and to ensure its continuity and required updates during changing circumstances. OPTEK’s Quality Management System meets all requirements of ISO/TS 16949:2002 and no exclusions are applied. This quality manual describes the Quality Management System of OPTEK. Quality Management Systems . the terms and definitions for the automotive industry specified in clause 3. Sensors can be standard product or custom made to customer’s specification. to inform OPTEK’s customers and other interested external partners about OPTEK’s Quality Policy. to provide effective communication and control of quality related activities and a documented base for quality system audits.1 of ISO/TS 16949:2002 are applied. • for external use. automotive engine and door controls and ignition security and fiber optic data communication applications. to communicate to employees the company’s Quality Policy and quality objectives. and demonstrates compliance with customer and regulatory requirements. Quality Management Systems . is focused on the enhancement of customer satisfaction through continual improvement of processes and products. Juarez manufacturing site. Quality Management Systems . Carrollton. and measures of compliance with the requirements of ISO/TS 16949:2002. to make the employees familiar with the method of compliance with ISO/TS 16949:2002 requirements.

1. etc. are available to ensure the effective operation and control of the processes of the Quality Management System. Manufacturing. documented as required.Page No. operating procedures. It is the responsibility of the Management Representative and Department Heads to ensure that the activities/processes included in the scope of this Quality Management System are identified and are performed in compliance with ISO/TS 16949:2002. 1 Management Processes 1. quality plans.1 QMS General Requirements a) Operational and administrative activities affecting quality of the departments Engineering. . Toolroom. Warehouse. utilizing tools such as process maps. d) It is the responsibility of the President/CEO. Quality Assurance.1 Quality Management System Implementation & Maintenance It is the responsibility of the Management Representative • to ensure that the Quality Management System of OPTEK is established. Engineering. Reporting to the President/CEO and his Executive Staff are the department managers of Quality Assurance. Sales and Customer Service and Quality Management System Administration are in compliance with ISO/TS 16949:2002. Sales and Administration. Manufacturing.: 7 of 46 Revision: 0 Issued: 2004/Feb/02 Quality Manual The quality manual includes the scope of the Quality Management System with no exclusions from the requirements of ISO/TS 16949:2002 and their justification. b) It is the responsibility of the Management Representative and Department Heads to ensure that the sequence and interaction of processes or activities of this Quality Management System are determined in a suitable manner. makes reference to applicable operating procedures and other pertinent documents. Management Representative and the Department Heads to ensure that the necessary human and material resources. Process Map #001 is a description of the Quality Management System interaction of processes Management Structure The management of OPTEK consists of the President/CEO. as well as the necessary information. Purchasing. c) It is the responsibility of the Management Representative and Department Heads to apply the necessary techniques and criteria in order to verify that established processes/activities and their implemented controls are effective. managed and maintained according to the requirements of ISO/TS 16949:2002 • to continually improve the effectiveness of the Quality Management System 1. implemented. flow charts.

These implemented controls however do not absolve OPTEK from the responsibility of supplying products that meet customer requirements.3 Control of Nonconforming Product.5. g) QMS Documentation requirements As a minimum. which affect product conformity.2. operation and control of processes of the Quality Management System • records required by ISO/TS 16949:2002 and by OPTEK to ensure appropriate control and evidence of compliance with requirements.: 8 of 46 Revision: 0 Issued: 2004/Feb/02 Quality Manual e) It is the responsibility of the Management Representative and Department Heads to ensure that the processes / activities which are part of the Quality Management System are monitored.2 Internal Audit. are outsourced. 4. . 8.2. the Management Representative and Department Heads ensure that action is taken to obtain expected results of processes/activities. control plans and other documents needed by OPTEK for the effective and efficient operation of the Quality Management System. describing the Quality Management System of OPTEK and its compliance with ISO/TS 16949:2002 2) Operating procedures.3 Preventive Action • other documents needed by OPTEK for the effective planning. as well as the continual improvement of these processes/activities.2 Training.5. master lists. operating instructions. records are created as required by ISO/TS 16949:2002.4 Control of Records. as well as records necessary to meet other internal and external requirements. work instructions. The document structure of OPTEK’s Quality Management System consists of two levels: 1) The Quality Manual. f) As required. In the event that processes. forms. measured and analyzed regarding their achievement of planned results.3 Control of Documents. quality plans. In addition.2.Page No.2.2. It is the responsibility of the Management Representative to ensure the availability of corporate documents of the Quality Management System and documents required by ISO/TS 16949:2002. 8. the documentation of OPTEK’s Quality Management System includes • a Quality Policy and objectives • this quality manual • required documented procedures or maps for ISO/TS 16949 clauses: 4. Quality Assurance via Supplier Quality establishes and implements the necessary controls for approval processes to ensure conformance to specified requirements. 8.2 Corrective Action and 8. 6.

1. The effectiveness of these procedures is measured through customer satisfaction surveys. which are part of Management Reviews (see 2. work instructions. including product realization processes and support processes.4).3 Customer Focus The President/CEO ensures that procedures for determining and meeting customer requirements are established and implemented. OPTEK is committed to its Quality Management System. 1. the President/CEO ensures that: • a corporate Quality Policy is established • quality objectives are established by selected departments based on the company business plan • the importance of meeting customer requirements and statutory and regulatory requirements is part of the training of each employee (QS02.1. Quality Objectives and will continually improve their effectiveness. 1.4 Quality Policy The management of OPTEK has developed a Corporate Quality Policy. efficiency and proper functioning of the Quality Management System. which meets the needs of OPTEK and its customers. 1.2.: 9 of 46 Revision: 0 Issued: 2004/Feb/02 Quality Manual It is the responsibility of the Department Heads to ensure the development and availability of documented procedures. operating instructions and any other documents related to their departments. Jerry Gallagher President / CEO February 2004 . yearly management reviews are conducted to verify the effectiveness. implementation and optimum functioning of the Quality Management System and the continual improvement of its effectiveness. competitive products on time to meet the requirements of our customers.2 Management Commitment The management of OPTEK is committed to the development. that are necessary to ensure the effective implementation. In order to provide this evidence.1.1 & 1. MF09) • resources for the implementation and maintenance of the Quality Management System and its processes are provided in a timely manner • at a minimum. Corporate Quality Policy OPTEK is dedicated to delivering defect-free.Page No.1. control and functioning of the Quality Management System and its processes.

Planning activities are documented and are consistent with other requirements of the Quality Management System. implemented and approved. Updated charts are distributed to Department Heads and are available to employees on a need to know basis.6 Responsibility and Authority It is the responsibility of the Management Representative to develop and maintain an organization chart of OPTEK. 1. that changes resulting from planning activities are coordinated and implemented in a controlled manner. operating procedure. flow chart. etc for his/her department.5 Quality Management System Planning In the first and the third quarter of the year. The output of these planning activities includes the identification of required resources. that changes to the Quality Management System are documented. Each Department Head develops and maintains a process map. as well the coordination of improvement opportunities.1. showing the workflow of the department as well as evidence of compliance with the requirements of the quality system. The General Requirements of clause 4. It is the responsibility of the Management Representative to ensure that resulting organizational changes and their consequences are identified and defined. and provides a basis for the establishment and review of quality objectives.: 10 of 46 Revision: 0 Issued: 2004/Feb/02 Quality Manual It is the responsibility of OPTEK’s management to implement and maintain this Quality Policy.Page No. coordinate and plan the efficiency and effectiveness of the Quality Management System and the realization of established quality objectives of the departments. for meeting internal requirements and customer requirements. The Quality Policy includes OPTEK’s commitment for continual improvement.1. The Quality Policy is made known within the organization and understood and adhered to by employees. quality plan. During management reviews. results from audits of the Quality Management System as well as permissible exclusions according to ISO/TS 16949:2002 are considered. the Management Representative calls for a meeting of the Department Heads with the purpose to review. the Quality Policy is reviewed for its continuing suitability. Note: the Quality Planning Team under the responsibility of the Manufacturing Department performs Quality planning for manufacturing process activities. . 1.1 of ISO/TS 16949:2002 are included in this planning process. and that the Quality Management System is properly maintained during these changes. As appropriate.

Department Heads ensure that the responsibility of employees or functions whose activities affect quality.6. are defined in procedures and job descriptions. The Department Head is notified of any identified nonconformity or deficiency where the correction or prevention of such nonconformity or deficiency is out of the employee’s scope of responsibility.3 Individual responsibility All employees follow the policies and guidelines outlined in the quality manual and in established procedures. documented and met. It is the duty of each employee to inform the Department Head or the Management Representative when performed activities do not match the established procedures. or personnel in Production and Warehouse.: 11 of 46 Revision: 0 Issued: 2004/Feb/02 Quality Manual 1. that the department’s personnel adheres to all applicable procedures and work instructions and participates.6. which relate to activities under the department’s responsibility. to inform the responsible Department Head of any nonconformity of products or processes. as appropriate. defined. It is the responsibility of the Department Heads to ensure that customer requirements and customer expectations. Corrective action is taken as appropriate. or when required.2 Departmental responsibility for quality The responsibility for quality in each department rests with the Department Head. or when established procedures and work instructions are unclear or ambiguous. Documents are updated as required. It is ensured that an employee responsible for quality is present at all times during production. The Department Head is responsible for the development and approval of the department’s procedures and work instructions. . are identified. 1. In the event of nonconformity in production.Page No. all personnel are responsible for product quality and have the authority to stop production in order to correct any quality problems. the Department Head can transfer the nonconformity to the Quality Planning Team for review and action. employees are made aware of the importance to meet customer requirements and expectations. If necessary.1. In yearly performance reviews.1 Responsibility for quality It is the responsibility of personnel in Quality Assurance.6. and are assessed and re-defined as necessary. including action for the review and improvement of processes. 1.1. these responsibilities for quality. together with other responsibilities of the function. are reviewed and discussed between the Department Head and the employee. in the quality improvement process. The Department Heads ensure that the department staff understands and follows the applicable policies and guidelines outlined in the Quality Manual. In addition.1.

with external customers and suppliers and other external partners and authorities • promoting the awareness of customer requirements and expectations throughout the company The Management Representative is responsible for the overall coordination. including needs for improvements • the proper coordination . has the defined authority and responsibility for • ensuring that a Quality Management System is established. implemented and maintained in accordance with the requirements of the international standard ISO/TS 16949:2002 • reporting on the performance of the Quality Management System to management for review and corrective action. including quality objectives for other departments • quality planning activities • product design and development • communication with customers on technical issues • customer prototype support Manufacturing: • recommendations for corporate quality objectives.1. including quality objectives for other departments .7 Management Representative The management of OPTEK appoints a Management Representative who.Page No.1.of quality related issues and activities within the company. Responsibilities related to customer requirements include: Sales: • coordination of issues related to customer requirements • recommendations for corporate quality objectives. irrespective of other duties and responsibilities. 1.: 12 of 46 Revision: 0 Issued: 2004/Feb/02 Quality Manual 1. and the direct responsibility of addressing customer requirements to the Department Heads of Sales. implementation and administration of the Quality Management System.where required .7. Engineering and Manufacturing.1 Customer representative The management of OPTEK has assigned the inter-departmental coordination of customer requirements to the manager of the Sales Department. including quality objectives for other departments • conveyance of temporary deviations to customers • analysis of feedback from customers regarding nonconformities • follow-up on corrective actions Engineering: • recommendations for corporate quality objectives.

9 Human resources .1. Qualification requirements include education.shipping inspection The Sales Department is informed of corrective actions taken by the responsible department regarding the compliance with customer requirements. MF01) or other actions are taken in order to meet defined qualification requirements.General It is the responsibility of the Department Heads to identify qualification requirements of functions or personnel assigned to defined activities that affect quality of product.1. skills.2 Product design skills It is the responsibility of Engineering to ensure that personnel with responsibility of product design are qualified for the job and have the necessary skills and experience as specified in the applicable job description.1. The effectiveness of provided training or of related actions is evaluated. experience and other qualifications are maintained. are available in a timely manner. experience) for each job are identified.: 13 of 46 Revision: 0 Issued: 2004/Feb/02 Quality Manual • • • special training requirements for production and warehouse production planning issues related to customer supplied products (in coordination with Purchasing and/or Supplier Quality Engineering) • delivery requirements . In the department’s budget are provisions for the employment and assignment of qualified and trained personnel. .Page No. 1. which have been identified by the Department Heads during budget planning and quality planning. skills and experience as appropriate. training. Related expenses are included in the company’s financial budget. Employees are made aware of the importance and the impact of their work in relation to product quality. to the achievement of quality objectives and customer satisfaction Records of employees’ education.8 Provision of Resources Management ensures that approved material and human resources. 1. This refers to resources required for the implementation. Training is provided to employees (QS02. training. awareness and training Department Heads ensure that the qualification requirements (such as education.9.9.1 Competence. Also included are resource requirements for new projects and other quality related activities. determined and documented in job descriptions. 1. 1.1. for meeting customer requirements and achieving customer satisfaction. maintenance and continual improvement of the processes of the Quality Management System.

1. Personnel performing activities that can affect quality are informed of potential consequences to the customer in the event that defined requirements will not be met (QS02). and criteria for product acceptance Records for providing evidence that manufacturing processes.1. are trained on-the job. the planning process covers provision of resources necessary. Performance reviews conducted by the Department Heads include and document the degree of employee’s awareness regarding the importance of their work and their contribution in achieving quality objectives.9.3 Training The Management Representative establishes and maintains the documented procedure (QS02 Training) for identifying training needs and for providing required training to employees who are performing activities affecting product quality.Page No. quality objectives and quality requirements for product related to the planning project are established by the quality planning team.10 Planning of Product Realization The Engineering Department is responsible for the quality planning (EG01) of the production processes of new products and for changes of existing products. 1.1.9.1. The procedure includes training for the fulfillment of specific customer requirements. to motivate employees in accomplishing quality objectives and to participate in the continual improvement process. advantages. Planning activities are consistent with other requirements of the Quality Management System. challenges and past achievements of these activities. The HR Representative (MF09) provides training for safety and the handling of hazardous materials. monitoring. Prior and during the planning process.: 14 of 46 Revision: 0 Issued: 2004/Feb/02 Quality Manual 1. the Management Representative publishes quarterly at least one article in the company’s bulletin regarding the importance. inspection and test activities. and manufactured product meet requirements are defined and specified. manufacturing processes and documents. .5 Employee motivation and empowerment To promote innovation. 1. Promoting the awareness for quality and technology to all employees is part of this process. An alternative would be to post these articles on the company’s bulletin boards/electronic bulletin boards. As appropriate. This applies only to on-site contracted personnel. validation.1. assigned to new or modified responsibilities affecting product quality.9.4 Training on the job Department Heads ensure that personnel. required verification.

4 Change control Changes to production processes (EG01). 1. the Quality Policy and quality objectives. approved by the customer.: 15 of 46 Revision: 0 Issued: 2004/Feb/02 Quality Manual 1.1. additional verification/identification requirements are met.1 of ISO/TS16949. management and the Management Representative have a formal meeting to discuss and review (Process Method #002) the continuing effectiveness and adequacy of the Quality Management System. the following inputs are to be considered for at least one meeting during the year: .10. Records of management reviews are maintained.Page No.10.10. are assessed. For proprietary designs.1.1 and 8.1.4. If requested by the customer.2. validated and approved by Engineering prior to use and implementation. Management is kept informed on the status of follow-up activities. as well as the assessment of improvement opportunities based on the review and analysis of performance trends.2 Management Review 1. 1. Review) At planned intervals. achievement of quality objectives and customer satisfaction. The Management Representative. 1.Quality Management System Performance (Mgmt. This review covers all clauses of the Quality Management System. ensures that the required data and documents are available for management review. the impact of changes is reviewed with the customer.1 Review Input As a minimum.Supplemental Customer requirements and references to technical specifications are included in the quality plan. writes the minutes of the meeting.1 General .1. 1.5. prepares the agenda of upcoming meetings. Department Heads and employees are invited to attend the meeting when issues of his/her area of responsibility are discussed. including changes to products/materials from suppliers. informs results to the Department Heads and individuals concerned and follows-up on required actions resulting from these meetings. with the input from management.1.2. and the cost of poor quality according to clauses 8. As required.10. as required.3 Confidentiality Confidentiality of information and data about customer-contracted products/projects is ensured (EG01). 1. Acceptance for attribute data sampling is zero defects (EG01). The review includes the evaluation of the need for changes to the Quality Management System.2 Acceptance criteria Acceptance criteria are defined in the planning process and.1 Planning of product realization .

excessive freight charges. analysis of field-failures (returns. their impact on quality. safety. including performance trends status and effectiveness of corrective and preventive actions follow-up actions from previous management reviews planned changes that could affect the Quality Management System assessment of improvement opportunities and recommendations for improvements employees’ knowledge. based on the analysis of collected data.Page No. including those specified in the business plan achievement of departmental quality objectives effectiveness of continual improvement activities of products. which includes: quality system audits conducted by the Registrar internal quality audits customer satisfaction surveys and other customer feedback regarding customer satisfaction customer complaints suppliers performance product and service quality and nonconformities direct and indirect costs and benefits of the quality system (relation cost . at all levels human resources. warranty repairs). incl. training and staffing requirements suitability of working environment availability of material resources effectiveness of quality planning (quality system.: 16 of 46 Revision: 0 Issued: 2004/Feb/02 Quality Manual • • • • • • • • • • • • • • • • performance of production processes. returns. and Quality Management System results of internal and external audits of the quality system. etc. design/development of products and processes) achievement of corporate quality objectives. processes. audits of manufacturing processes statistical results of operational performance. directives and procedures.scrap. product conformity. environment the impact or potential impact of changes that could affect the Quality Management System opportunities for improvement resulting from additions or changes . rework. understanding and adherence to quality policies. and their involvement in the quality improvement process availability and effectiveness of internal and external information within the company.benefit) cost of poor quality . warranty repairs.

and are defined in such a way that their degree of achievement and results can be measured. include . • • • • • • Provide Exemplary Customer Satisfaction Be a leader in Advanced Technology Development Eliminate waste wherever it exists Be the industry benchmark for manufacturing capability Provide a work environment that promotes competency. The completion and achievement of yearly quality objectives included in the business plan and departmental quality objectives are reviewed during management review regarding their level of achievement.objectives to meet product requirements (see 1. empowerment and accountability Deliver exceptional financial performance over time .2 Review Output Results of the assessment and conclusions of management reviews include the following output: • effectiveness of corrective and/or preventive actions • the suitability and effectiveness of the Quality Management System • improvement of the effectiveness of the Quality Management System and its processes • improvement of product with focus on customer requirements • availability of human and material resources • suitability of the corporate Quality Policy • frequency of Management Reviews • required corrective and or preventive actions regarding items reviewed 1. teamwork.2.1. Corporate quality initiatives Based on the corporate Quality Policy. Established quality objectives are consistent with the Quality Policy. At least two quality objectives of the departments Manufacturing and Quality Assurance are related to the performance of product. Yearly quality objectives and measurements are established by Department Heads for their departments based on these Quality Initiatives. the management of OPTEK has established the following corporate quality initiatives based on one premise – that of Exceeding the Customer’s Expectations. These quality initiatives will be reviewed each year to ensure alignment with the business plan. management defines Corporate Quality Initiatives in the Business Plan.1.Page No.as appropriate .2. Management approves these departmental quality objectives.: 17 of 46 Revision: 0 Issued: 2004/Feb/02 Quality Manual 1.10).2 Quality Objectives Each year.

Goal is to establish a base line measurement & reduce the average by 50% during the next 3 years Specific measurements are tracked to demonstrate results with continual improvement The end result of this process is to clearly tie the business plan into operational terms that have meaning to front line personnel at all levels within the organization.: 18 of 46 Revision: 0 Issued: 2004/Feb/02 Quality Manual The translation from a Corporate Quality Initiative to a measurable index for demonstrating results and continual improvement is demonstrated in the following example: Corporate Business Plan Corporate Quality Initiatives Consistent compliance with customer requirements Established by top management to set the direction for the business Corporate Quality Objectives Meet on time shipment requirements Deployment strategies are Optek’s Quality Objectives Sales Department will improve accuracy in the identification of customer & product info during the quote cycle – see Process Map #004 Objectives are deployed to the function or department with specific goals defined Measurement: Track the number of errors in this information & graph.Page No. Our business objectives are our Quality Objectives .

: 19 of 46 Revision: 0 Issued: 2004/Feb/02 Quality Manual Based on internal and external audit results and statistics issued by the Management Representative (QS04). the Management Representative develops and distributes quarterly statistics (QS04). the Department Heads of Administration. for product verification (process capability. Training records are maintained (QS02). dependability analysis.). This includes statistical methods for product development (variation analysis. customers’ business disruptions (QS06). Sales. The departmental quality objectives for the coming year are submitted to the President/CEO for review and approval. variation analysis. As required.). 1.Page No. these quality initiatives are reviewed during management reviews regarding their continuing suitability. which include customer complaints and feedback. Manufacturing.2. Toolroom and Quality Assurance establish quality objectives for his/her department.2. These statistics are analyzed by Department Heads and corrective and preventive action for the continual improvement of the Quality Management System is taken as appropriate.4 Customer Satisfaction Periodic customer satisfaction surveys (QS07) are conducted by management to verify if customer satisfaction has been achieved. Departmental quality objectives Each year. Survey results. control charts.2. A summary of the achievement of the department’s quality objectives of the past year is documented by the applicable Department Head and submitted to the President/CEO. Warehouse. the conformity of the Quality Management System and its continual improvement. 1. and other processes. 1.3.1 Identification of Statistical Tools During product quality planning (EG01). 1. . customer returns of nonconforming product (217-0027-001) and delivery performance (QS04) are analyzed and evaluated (QS05). Engineering. etc. etc.3.2. management takes corrective or preventive action. appropriate statistical tools are determined for each process and are included in the control plan.2 Knowledge of Basic Statistical Concepts Department Heads. The Management Representative monitors the effectiveness of these corrective or preventive actions. These quality objectives are in accordance with the corporate Quality Policy and are focused on the improvement of departmental processes/activities (see process maps).General In order to demonstrate the conformity of manufactured product. with the assistance of the Management Representative ensure that personnel are trained in the use and application of basic statistical concepts defined by quality planning and used in their respective departments.3 Measurement Analysis & Improvement .

root causes are determined and required action is taken or recommended as appropriate. . Improvement It is the responsibility of the Management Representative to form and implement a Quality Planning Team for the handling of assigned activities related to the Quality Management System. decision making and longer term planning. monitor results. to make recommendations for preventive actions and quality improvements. and by Department Heads regarding the performance and suitability of activities and processes under their responsibility. Nonconformities and deficiencies are analyzed.5 Analysis and Use of Data The Management Representative issues statistics regarding the performance of the Quality Management System (QS04) thru the analysis and use of data. product quality. A summary report is issued by the Management Representative. The purpose of the Quality Planning Team is to review. Analysis results of statistics and actions are reported by the Department Heads to the Management Representative who monitors the progress and results of these actions. Manufacturing. The Management Representative controls and coordinates the implementation of required corrective or preventive actions. Engineering. This includes the analysis of customer complaints (QS06) and customer returns (QA08). The statistics are analyzed by the Management Representative regarding the effectiveness. and supplier performance. analyze and make final decisions on Corrective Action Requests (QSW01) and Quality Improvement Proposals (QSW03). suitability and opportunities for improvement of the processes of the Quality Management System.: 20 of 46 Revision: 0 Issued: 2004/Feb/02 Quality Manual 1. As required and/or decided by management. to coordinate and implement preventive actions and quality improvement projects. providing information on: customer satisfaction or dissatisfaction. to determine customer related trends and correlation for status review. characteristics and trends of processes and products including opportunities for preventive action. Members should be from Quality Assurance. In addition.Page No. and to provide a forum for any quality issue which requires a crossfunctional approach. selected Quality Improvement Proposals are referred to the Quality Planning Team for review regarding their feasibility and benefits. Ratings on supplier performance are issued by Purchasing and/or Quality Assurance (PU04). Purchasing and any other additional members deemed necessary. and an information system for reporting of product information related to usage. Sales. trends in quality and operational performance are compared with progress toward objectives and lead to action to support: the development of priorities to resolve customer-related problems.2.

2. In monthly meetings with the production staff.3. 1. The Management Representative. ensures that required communication and information between departments and functions is defined in documented procedures. Manufacturing process improvement It is the responsibility of personnel in Manufacturing to continually monitor the performance of manufacturing processes regarding conformity with product characteristics and process parameters. with the assistance of the Department Heads. Continual improvement activities include .3. coordination and control of activities for continual improvement (QS11) is the responsibility of the Management Representative and the Quality Team. memos.2 Customer Communication In order to meet customer requirements and to ensure the proper and effective communication between the various departments within OPTEK and the customer.the following: • activities of the Quality Team under the responsibility of the Management Representative • actions on results from analysis of data (QS04) • evaluation of suppliers (PU04) • achievement of departmental quality objectives • results from internal quality audits • quality improvement proposals (QIP) • corrective actions and preventive actions (CAR) • periodic review of controlled documents (QS01) The objectives of the corporate Quality Policy are taken into consideration for planning of improvement. and staff meetings. Any communication problem regarding the Quality Management System is reported to the Management Representative for corrective action.1 Internal Communication Effective internal communication is essential for the proper functioning of the Quality Management System. process performances of production areas are analyzed. 1. and opportunities for improvement are identified and implemented (QS11).: 21 of 46 Revision: 0 Issued: 2004/Feb/02 Quality Manual 1. is distributed to functions concerned and is attached to the main directory available at the front lobby. the effectiveness of continual improvement is reviewed and opportunities for improvement are identified. . Sales establishes a list with some main contacts within OPTEK regarding customer inquiries. This list is updated as required. During Management Reviews. forms and/or documents.6 Continual Improvement The planning.Page No.but are not be limited to .3 Communication 1.

4 Internal Auditing 1. Audit results are recorded and corrective action is taken as required. Due to special .4. the Management Representative is responsible for internal audits. 1. It is the responsibility of Sales. including all shifts of these processes. Audit activities are assigned to personnel not responsible for the area or activity to be audited. in order to effectively communicate and interchange information with the customers. The Management Representative ensures that audit results are part of Management Review. The Management Representative selects the auditors and ensures that they have required experience and knowledge to perform auditing activities.4. As appropriate.: 22 of 46 Revision: 0 Issued: 2004/Feb/02 Quality Manual Internal and external communication related to the planning of products and processes (EG01) is defined by Engineering and/or Sales and/or the quality planning team. Records of internal audits are maintained.2 Internal Audit Plans Internal audits cover the entire Quality Management System and its processes. as applicable. and that it meets the requirements of OPTEK. to develop. with the assistance of the IS-department. objectives and results. Audits are scheduled on the basis of the importance of the activity to be audited. and are scheduled according to a yearly auditing plan and schedule prepared by the Management Representative (QS08). Audits do also verify if the Quality Management System is effectively implemented and maintained.1 Internal Audit of the Quality Management System Following the established documented Process Map #002 Internal Quality Audits. management is informed of the results of audits and follow-up audits and takes additional corrective action. implement and maintain a computerized system (such as EDI) for the receipt of planning information of customer orders.Page No. including planned actions. It is the responsibility of Engineering. Internal audits are planned and scheduled in such a way that all applicable clauses of ISO/TS 16949:2002 and other additional quality system requirements are audited regarding compliance with this implemented Quality Management System and ISO/TS 16949:2002. with the assistance of the IS-department. follow-up audits are conducted to ensure that corrective action was implemented and is effective. 1. Where applicable. shipping schedules and shipping information. to install and use electronic communication and design systems (such as CAD) that are compatible with the customers’ systems.

such as nonconformities and customer complaints. . 1. A summary of audit results of the manufacturing processes is prepared and included in Management Reviews.5 Corrective & Preventive Action 1. physical product can be inspected and tested by the auditor to confirm the product’s conformance to requirements and proper functionality. 1. inspection and test results of product in process and finished product are audited to verify conformity to specified requirements.4.5 Product Audit During the auditing of process in Manufacturing and the Warehouse. nonconformities are identified. the Management Representative coordinates with the Manufacturing department the auditing of all manufacturing processes. 1. As appropriate. corrective action is evaluated and defined. It is the responsibility of the Department Heads to establish and maintain records of corrective actions and their results. recurrence of the nonconformity is prevented. 1. Incoming product. It is the responsibility of the Department Heads to inform the Sales/Service department of all customer complaints (QS06) and related corrective actions.4 Manufacturing Process Audit In addition to the normal internal audits of the Quality Management System.3 Internal Auditor Qualification It is the responsibility of the Management Representative to ensure that internal auditors of the Quality Management System have the necessary experience and qualification for performing internal quality audits (QS08).Page No. and the effectiveness of corrective action taken is reviewed. Training needs are identified and training is provided as required (QS02).5. the auditing frequency is increased as appropriate. product in inventory and product ready for shipping is audited regarding compliance with packaging and labeling requirements. Following the established procedure for corrective action (QS10). Corrective actions are appropriate to the importance and impact of the addressed nonconformity.: 23 of 46 Revision: 0 Issued: 2004/Feb/02 Quality Manual circumstances. Audits of manufacturing processes are performed at least once per year. corrective actions and their results are recorded. root causes are determined. Responsible personnel in Manufacturing take required corrective actions.4.1 Corrective Action It is the responsibility of the Management Representative to implement and maintain the documented procedure QS10 Corrective Action that defines a corporate approach for corrective action.4.

is used as appropriate.1 Problem Solving To determine the root cause of a problem or deficiency. update all related documents with preventive action taken Department Heads analyze and evaluate data of statistics (QS04) and perform periodic reviews of procedures (QS01) in order to detect deficiencies and problems and to take preventive action as required. It is the responsibility of the Department Heads to establish and maintain records of preventive actions and their results.5.5.: 24 of 46 Revision: 0 Issued: 2004/Feb/02 Quality Manual 1.1.1.5. and to establish required corrective action.3 Corrective Action Impact As applicable.5.2 Preventive Action It is the responsibility of the Management Representative to implement and maintain the documented procedure (QS09) Preventive Action that defines a corporate approach for preventive action to prevent the occurrence of potential nonconformities. 1. . Any employee can suggest a preventive action to the responsible Department Head by initiating a CAR (QSW01).2 Error-Proofing As appropriate.1. or any other suitable method.4 Rejected Product Test / Analysis Product returned from customers (QA08) is analyzed by Quality Assurance in order to initiate appropriate corrective action and to prevent recurrence (Process Map – Process Flow). • • • • • • • The process of preventive action includes the following steps: identify potential nonconformities. the Quality Team applies error-proofing methods in the corrective action process to prevent recurrence of the problem. deficiencies or problems. 1. 1.1. the Quality Team applies implemented corrective action to other similar processes or products in order to correct nonconformity.Page No.5. deficiencies or problems determine the root causes determine the necessary preventive action implement the action follow-up on status and results review the effectiveness of preventive action. a disciplined problem solving method as outlined in the work instruction QSW02. The Management Representative ensures that relevant information on preventive action is on the agenda of management reviews. 1.

or any other requirement of importance. the quality planning team and Manufacturing to apply.1. The Sales department or responsible Department Head also ensures that during set-up and maintenance of new customer files (217-0020-001). document and control special characteristics designated by the customer. Process Map # 004. as well as other requirements identified during product development and quality planning (EG01). the order or quotation is reviewed to ensure that • the product and customer requirements are clearly defined and documented . and understood by all functions concerned.: 25 of 46 Revision: 0 Issued: 2004/Feb/02 Quality Manual 2 Realization Processes: 2.2 Review of Requirements Related to Product. determined and documented by the responsible department.1 Requirements Determination & Review 2. represented by the Quality Planning Team. 217-0011-001). or the acceptance or confirmation of an order (Process Map 012) from a customer. with focus on processes affecting safety.1 Determination of requirements related to product It is the responsibility of the Sales department to ensure that customer requirements related to product are identified and defined.Page No. Symbols to be used for these special characteristics are those designated by the customer or other commonly used symbols used in the industry.1. customer requirements are identified and documented. Customer-designated special characteristics It is the responsibility of Engineering. Department Heads ensure that other requirements specified by customers. 2. as well as customer needs and expectations are identified. Manufacturing prepares production schedules and material requirement reports to ensure availability of product for the fulfillment of customer orders. to identify and determine requirements not specified by the customer but necessary for the proper and intended use of the product or service. 217-0020-001) SDQA . It is the responsibility of Engineering. including regulatory and statutory requirements Process Map #013 – Product Realization. Based on sales forecast and/or other special requirements documented by the Sales department. customer returns (217-0027-001) and shipping of products. order taking and processing (217-0014-001. Once these requirements are determined. compliance with regulatory requirements. In addition to customer requirements included in design. Manufacturing Feasibility The Sales department is responsible for the review of product specifications and customer requirements (Process Map # 003. the fit or function of a product. and that these requirements are met as appropriate. and other functions concerned are informed as appropriate. they are used as input for product development and quality planning. development and quality planning (EG01). Prior to the submission of a quotation (Process Map #011)to the customer.

During the planning process (Design Control Handbook).2 Design and Development Planning The planning and control of design and development of product is the responsibility of Engineering (EG01). 2. confirmed and documented (217-0020-001).2. Waiving the requirement for a formal review requires customer approval. and the development and review of FMEAs and control plans. the originating department submits a Redfolder (217-0020-001) request to Engineering. As the planning process develops. it is ensured that relevant documents and data are updated and that other functions concerned are notified. As required. In the event of changes to product requirements.2 Design & Development 2. Records of contract reviews are maintained. planning output is updated as appropriate.3 Multidisciplinary Approach Organizational and technical interfaces. and a risk analysis is performed. It is the responsibility of the Project Team Leader to ensure the effective communication and distribution of information between the team members and other functions participating in the planning process.4 Design and Development Input The originator of the Greenfolder (217-0010-001) identifies and documents the input requirements.1 Design and Development If there is a need for the design and/or development of a new product or for a change of the design or manufacturing process of a product.2. which are reviewed by Engineering. Manufacturing feasibility is analyzed.: 26 of 46 Revision: 0 Issued: 2004/Feb/02 Quality Manual • • • OPTEK has the capability to meet the requirements of the quotation or order requirements of verbal orders are recorded and confirmed prior to acceptance any differences between the customer’s order and OPTEK’s quotation are clarified and resolved. verification and validation of each design and development stage as appropriate. statutory and . are defined in the Project Plan and Schedule (Design Control Handbook) and are reviewed during each meeting of the team. 2. The results of reviews and required actions are documented. defines the review. Input for product design and development includes functional and performance requirements. the project team determines the stages of the design and development project. 2.2. and assigns responsibilities of required tasks and actions. 2. including customer communication. other functions are consulted within their areas of expertise. or other changes to a quotation or order.Page No.2. A multidisciplinary approach is also used for the development and monitoring of special characteristics.

contains or makes reference to acceptance criteria and includes critical and crucial characteristics for safety and functionality of the product or process. process performance and other information and data to ensure that manufacturing processes meet requirements (Design Control Handbook). FMEAs and applicable documents in order to ensure proper identification of special requirements of product and processes (EG01). and any other identified requirements. product definitions. Any past experience or information from similar projects is applied as appropriate. Records of design input are maintained.2. product quality and performance objectives.Page No. Problems are identified and appropriate action is taken. 2.2.2.: 27 of 46 Revision: 0 Issued: 2004/Feb/02 Quality Manual regulatory requirements. missing or conflicting information is clarified and resolved with the originator of the request before proceeding with the project. and are submitted to the Management Representative for input to management reviews. Design outputs are reviewed prior to release. and customer requirements. special characteristics. Additional outputs for process design include drawings. Progress and end results of design and development planning (such as effectiveness. lead time) are recorded at defined stages of the planning. 2. capability. Records of design reviews and resulting actions are maintained. cost. costs.7 Design and Development Review. . Monitoring The Project Team performs formal design reviews to identify any potential problems in meeting requirements and design goals. control plans. customer requirements. 2. Additional outputs for product design include FMEAs.6 Design and Development Output The Project Team produces design output which is documented. meets design input requirements. targets for productivity.5 Special Characteristics Special characteristics for product and processes. Ambiguous. As applicable. are identified and included in control plans. Input for the development of manufacturing processes includes product design output data. FMEAs. is expressed in terms that can be verified and validated against design input requirements. manufacturing process design. design and development output provides data and information for product design. and which are specified by the customer or by OPTEK. as applicable (Design Control Handbook). design reviews and other defined output results.

2. Results of validations and necessary actions are recorded and maintained. Requests are reviewed and approved by Engineering.9 Design and Development Validation The Project Team performs design validation to ensure that the designed product meets defined customer/user needs and requirements. are documented (217-0010-001. As appropriate.11 Product Approval Process Sample submission of production parts (QA10) for consequent customer approval is the responsibility of the Quality Assurance.8 Design and Development Verification The Project Team performs periodic design verifications to verify that design and development outputs meet the design and development input requirements. 2. this validation should be performed prior to production. manufacturing location. As required. If possible. OPTEK is responsible for contracted materials and services. Processes. . equipment and materials used for the prototype should be the same as those used for final production runs. engineering change of production part. production part approval is extended for engineering approval of purchased products. Results of design verifications and resulting actions are recorded and maintained.2.: 28 of 46 Revision: 0 Issued: 2004/Feb/02 Quality Manual 2.12 Control of Design and Development Changes Requests for design and development changes. 2. In the event that services for prototype development are outsourced. However. partial validation is acceptable. Methods and guidelines specified by the customer are followed. Design Control Handbook). the product development includes the development of a control plan and a prototype (EG01). material suppliers and production process environment. Validation is according to customer requirements and includes program timing. including proposed changes from suppliers. Testing activities are monitored regarding timely completion and compliance with requirements. 2.10 Prototype Program If required by the customer.2. it is understood that OPTEK is still responsible for the quality and performance of the prototype.2. OPTEK provides technical assistance and support to contractors/suppliers. The Quality Planning Team properly validates engineering changes. Any change to these conditions requires customer notification and possible re-submission of production parts for approval.2. 2. Production part approval is requested for production parts.Page No. Results and necessary actions are documented and records are maintained. if required.

3 Supplier Quality Management System Development The Purchasing staff encourages suppliers to prepare for and/or implement the necessary procedures in order to meet the requirements of ISO 9001:2000 and to become certified.3.2 Regulatory Conformity Quality Assurance verifies that incoming purchased products and materials are in compliance with applicable regulatory requirements (QA02). delivery performance to acknowledged date and continual improvement. the assistance of the Management Representative is requested.: 29 of 46 Revision: 0 Issued: 2004/Feb/02 Quality Manual 2.3 Purchasing 2. Records of evaluation and selection of suppliers as well as related actions are maintained by Supplier Quality Engineering (SQE) and/or Supplier Quality Development (SQD). Suppliers are evaluated and selected according to defined selection criteria and their ability to supply product that meets specified requirements. 2.3. products or services are only purchased from the customer-designated supplier. problems reported by the manufacturing involving supplied product.1 Purchasing Process The Purchasing department is responsible for the effective and efficient operation of purchasing functions and activities (PU01. Materials supplied by customer-designated suppliers are subject to receiving inspection by Quality Assurance (QA02).3. Purchasing &/or Supplier Development follows up on the suppliers’ progress with the implementation of ISO 9001:2001 or an acceptable quality management system (Process Map: Supplier Development). the customer-approved supplier must be approved according to OPTEK’s approval criteria (PU04). For the supply of materials for other applications.Page No.3. PU03). 2. . material or service. PU02. it is the responsibility of the Purchasing department to ensure that these materials. Depending on the effect of the purchased product on the final product or production processes. Supplier performance is monitored per the Supplier Quality Requirements paragraph 4 page 12 through the evaluation of product quality. All suppliers receive the manual TT Electronics/OPTEK Supplier Quality Requirements as an initial step for getting familiar with quality system requirements.4 Customer-Approved Sources Where according to customer contract. a product or material is to be purchased from a customer-designated supplier. The customer must approve alternate suppliers for this product. As required. 2. Production materials. the type of control applied to the supplier and the method used for verification of purchased product are identified and established by Engineering and/or Quality Assurance. products and services are only purchased from approved suppliers (PU04).

and Quality Management System requirements.5 Purchasing Information For products and services purchased. cost competitiveness. The data describe and identify clearly the product to be ordered. As applicable. Supplier Quality Requirements) of approved active suppliers and distributes on a regular basis to the top suppliers.1 Infrastructure The required infrastructure and resources for manufacturing activities are identified during quality planning (EG01). processes and equipment. procedures. the initial evaluation of the supplier.: 30 of 46 Revision: 0 Issued: 2004/Feb/02 Quality Manual 2.6 Verification of Purchased Product and Incoming Product Quality The extent of quality control exercised over a supplier or over the supplied product is determined by Quality Assurance and depends on the importance of the product or product class (PU03). In the event that OPTEK or one of OPTEK’s customers wants to verify purchased product at the supplier’s premises. Incoming purchased product is submitted to an incoming inspection (QA02) performed and recorded by Quality Assurance when supplier product is noncertified. Suppliers are informed of their rating and corrective action is taken as required. requirements for the approval of product. 2. 2. this includes building facilities. these verification requirements and/or the method of product release are requested and defined by either Engineering. standards or other documents are referenced.Page No. problems reported by manufacturing involving supplied product. and are specified either in the purchase order and/or part specification. and/or the results of ongoing performance ratings of the supplier. Purchasing/Supplier Quality develops periodic performance ratings (PU04. Verification at supplier’s site does not exclude subsequent rejection after receipt at OPTEK or OPTEK’s customer. The adequacy of specified purchase requirements is ensured prior to submission to the supplier.4 Facilities & Equipment Management 2. continuous improvement efforts. delivery performance. Purchasing. statutory and regulatory requirements.4. 2. warehousing and transportation. necessary workspace and utilities as well as needed equipment and services such as maintenance. SQE and/or SQD ensures that required records are set up and maintained (PU02. as applicable.3. Records of supplier performance ratings are maintained. requirements for qualification of personnel. As appropriate. and/or type and extent of inspection performed by the supplier. others on request or at OPTEK’s discretion.3.3. Verification activities at the supplier’s premises are coordinated through the Purchasing and/or Quality department. PU03). including customer supplied product. and customer feedback.7 Supplier Monitoring Supplier performance is monitored through evaluation of product quality. Quality Assurance or Sales. .

4.4.: 31 of 46 Revision: 0 Issued: 2004/Feb/02 Quality Manual Management ensures the timely availability of identified and approved resources. Any issues or concerns regarding health and safety of processes are reported to the departmental representative.4.4.Page No.2 Contingency plans The Management Representative. These special conditions are included in the quality plan. New plans are developed as required.4. facility and equipment planning Plant. Accidents at the workplace are recorded (First Report of Injury & Supervisors Investigation Report) with copy to the HR Representative who keeps a master list of accidents for corrective or preventive actions. 2.1 Work Environment The quality planning team defines special conditions of the work environment that are necessary for the processes to meet defined requirements of product quality and regulatory requirements (EG01).1.2. with participation from Manufacturing. manufacturing plan.2. Contingency plans are reviewed in the first quarter of each year regarding their validity. . facility and equipment planning of the effectiveness of existing equipment and facilities are the responsibility of Manufacturing and involves departments and functions concerned. 2.1 Plant. Engineering and Sales. process sheet or other documents.1. 2. monitored and evaluated considering • • • • • human factors operator and line balance availability of supplies use of automation work plans Records of planning activities are maintained as per applicable master list of records. The productivity and effectiveness of existing operations is reviewed.2 Personnel Safety to Achieve Product Quality It is the responsibility of the Department Heads to ensure the safety of employees and to minimize risk of injuries when performing their duties.2 Work Environment 2. It is the responsibility of the Department Head to implement these requirements. The HR Representative forms the Health and Safety Committee that includes representatives of applicable areas. develops contingency plans to meet customer requirements in the event of a production halt or labor shortage. 2.

Manufacturing. The responsible Department Head ensures that customer owned product is identified. a visual inspection of products.4. 2. As required. Any loss.1 Control of Monitoring and Measuring Devices To ensure accurate and reliable monitoring and inspection results.3.Page No. The type of monitoring and measuring equipment/device/software to be used in Manufacturing.1 Customer Property Customer owned product supplied for production is inspected by Quality Assurance according to defined inspection requirements (QA02).3. process traveler and/or inspection reports (QA02. housekeeping procedures are developed and implemented by individual Department Heads. Toolroom and Engineering ensure that monitoring and measuring equipment and devices are controlled.3 Customer Property 2. by Quality Assurance and Toolroom. During periodic cycle counts conducted by designated personnel in Manufacturing or Warehousing.4. . QA04).: 32 of 46 Revision: 0 Issued: 2004/Feb/02 Quality Manual Product safety is addressed during the design and development process under the responsibility of Engineering. the Quality Assurance.4. calibrated and maintained (QA05). handled and shipped in an appropriate manner in order to ensure its suitable condition for use.4. stored.4. It is the responsibility of Manufacturing and Warehouse to ensure that production facilities and the warehouse are kept clean and in good order.2 Customer Owned Production Tooling It is the responsibility of the Toolroom & Manufacturing to ensure that customer owned tooling and fixtures are clearly identified with a metal plate or permanent marking method showing the ownership of the equipment.4 Control of Monitoring & Measurement Devices 2. including customer owned product. 2.2. damage or deterioration of customer-supplied product is recorded and the customer is notified. used. QA03. is performed to verify the product’s condition and proper identification.4.4. 2. and the required accuracy of these monitoring and measurement activities are defined during quality planning and specified in the manufacturing plan (EG01).3 Cleanliness of Premises It is the responsibility of management to ensure that the premises of OPTEK are kept clean and in a good state of order. 2.

4.4. and according to a recognized standard. If suspect product/material has been shipped.3 Calibration / Verification Records The department performing the calibration of monitoring and measuring devices is responsible for the record keeping of calibration activities. where no recognized standard is used. including recall of nonconforming product. it is verified and confirmed that the software produces defined results. the customers are informed and the product is recalled as required (QA06). . QA01). measuring equipment is • calibrated and/or checked in defined intervals or prior to use. • protected from damage and deterioration during handling. • adjusted and re-adjusted as necessary to ensure required accuracy • identified with a unique identification number and the current calibration status. the impact on products previously measured with this equipment is reviewed and validated (QA06) and an Out-Of-Calibration Report is initiated as appropriate.Page No. Corrective action on the measuring device or product affected is taken. maintenance and storage In the event that monitoring and measuring devices are found out of calibration. if required (MF03. 2. Records of these studies provide evidence of the variations present in the results of each type of measuring device and are taken into consideration when inspection reports are developed. To ensure valid results. the basis applied for the calibration is documented. previous measuring results are reviewed regarding their validity (QA06).4.2 Measurement System Analysis It is the responsibility of Quality Assurance to ensure that a Repeatability and Reproducibility study is conducted (QA07) for each measuring device referenced in control plans. When monitoring and inspection equipment is found out-of-specifications. • kept in a secure and restricted location to prevent misuse and improper adjustments that could invalidate calibration settings. and calibration results such as out-of-specification/conformity to specifications. Prior to the use of computer software for monitoring and measuring activities.: 33 of 46 Revision: 0 Issued: 2004/Feb/02 Quality Manual It is the responsibility of the applicable department to ensure that monitoring and measuring processes are capable for their intended purpose and are performed in a manner that is consistent with requirements. revisions due to engineering changes. These records include the identification of the equipment and the calibration standard. Records of these verifications are maintained 2.4.

4 2. the Engineering Department is responsible for the identification. which can be performed by the inhouse laboratory facility of the Quality Assurance department.4.3. Quality Assurance has specified and implemented technical requirements for the suitability of implemented procedures competency of personnel testing of product capability to perform these services correctly and according to pertinent process standards.4. #006.4.4. test and calibration. which defines the responsibilities for the development of controlled documents. including documents and data of external origin such as standards and customer drawings. qualified laboratories are used for inspection.1 Internal Laboratory It is the responsibility of Quality Assurance to define and document the scope of the capability of tests and inspection activities. It is the responsibility of the Management Representative to implement and maintain the documented procedure (Process Maps #005.4. If a specific calibration service cannot be performed by an external laboratory. identification and distribution. the review of related records 2.5 Company Control Specifics 2. Only laboratories are used which include in their defined laboratory scope the required service to be performed. revision status. Engineering documents developed by Engineering or engineering documents from the customer. Incoming customer engineering standards and .1 Document Control 2. or laboratories that are accredited to ISO/IEC 17025 or other equivalent national standard. and other contract services.5.: 34 of 46 Revision: 0 Issued: 2004/Feb/02 Quality Manual Laboratory Requirements 2.1 Control of Documents and Engineering Specifications Documents required by the Quality Management System are controlled documents.4.2 External Laboratory As required. as long as the requirements of clause 7. Following the documented procedure EG02 Document and Data Control. and which are either capable based on business history and/or previous services provided. document formats.1. including the distribution of these documents. the original equipment manufacturer or their accredited representative can provide this service. their approval for adequacy. changes and re-approval.5.4. 2.1 of ISO/TS 16949 are met.4.6. control and distribution of technical engineering documents. or in the absence of such a laboratory. and #007) Control of Documents.Page No. are recorded.

retrieval. data and operating instructions for the performance of manufacturing processes are developed and available to personnel. it is the responsibility of the IS Department to establish a schedule for producing back-ups of defined computer data. .3. and that obsolete documents retained for any purpose are clearly identified. are reviewed as soon as possible.5. by Engineering. Schedules for backup responsibilities and compliance are documented. It is the responsibility of the applicable Department Head to ensure that current revisions of controlled documents are legible. production processes. As required. It is also the responsibility of the Manufacturing department to ensure that the work environment is appropriate for the work being performed and meets statutory requirements. Manufacturing and Document Control ensure that the necessary documents. Included are procedures for release. including instructions for special processes. retention time and disposition of records according to the established documented procedure QS12. the equipment to be used. of conformance to requirements and of the effective operation of the Quality Management System. that obsolete copies are replaced and destroyed or invalidated.2 Records Control 2.5. and that activities for the monitoring and measurement of production processes are implemented and followed. The HR Representative is responsible for compliance with regulatory requirements (MF09). protection. readily available where needed. delivery and post-delivery activities. 2. 2. Department Heads are responsible for the proper identification. Records of implementation dates in production are maintained. Based on the output from quality planning (EG01). and are then distributed and implemented as required.1 Control of Production Manufacturing processes activities are performed under controlled conditions. storage. These documents or data describe in sufficient detail the product characteristics. including changes.Page No.5.1 Control and Retention of Records Records are maintained to provide evidence of activities and their results.5. The Manufacturing department ensures that operating instructions. are available at the workstation.: 35 of 46 Revision: 0 Issued: 2004/Feb/02 Quality Manual specifications. not to exceed two weeks.3 Control of Production Provision 2. These back-ups on tape or CD-ROM are kept in a secure place outside of the company’s premises. that production activities. verification results and SPC records are recorded. as well as the activities for monitoring and measuring of these processes.2.

statistical verification methods are used. The actual maintenance status of each piece of equipment is identified. If required. The maintenance system includes a MIN/MAX .3. Control plans are available for all production stages of products or parts. As applicable. Preventive maintenance objectives are established and documented in the first quarter of each year. logistics. 2.5. Pre-Launch control plans heed the outputs of DFMEAs and PFMEAs. 2. or any changes affecting the product.3. 2. In case of set-up difficulties. Designated staff in Manufacturing performs required preventive maintenance.inventory system of frequently used replacement parts . inspection activities.5. manufacturing processes.4 Verification of job set-ups Manufacturing is responsible for proper set-ups of production equipment. These documents are made accessible to personnel at the work place.3 Work Instructions It is the responsibility of the Department Heads to develop and maintain documented work instructions and operating instructions that are necessary for the performance of processes and activities affecting quality of products.2 Control Plan Control plans are developed during quality planning (EG01) and define the development of prototypes. as applicable. These objectives are evaluated at least yearly regarding their achievement and opportunities for improvement. as appropriate. including assembly.5. Quality Assurance performs a last-off comparison. control plans specify • the required controls for manufacturing processes • the methods used for monitoring applied controls over special characteristics (customer/OPTEK) • customer-required information • the reaction plan to be initiated when the process becomes unstable or not capable With changes of product specifications. control plans are updated by the quality planning team (EG01). such as the quality plan or control plan.3. First-Offs are approved by Quality Assurance. As applicable.: 36 of 46 Revision: 0 Issued: 2004/Feb/02 Quality Manual 2.5 Preventive and Predictive Maintenance A master list of machinery and equipment that requires preventive maintenance to ensure continuous process capability is developed and maintained by Manufacturing. supply sources or FMEAs.Page No.5. Work instructions and operating instructions are derived from the output data from quality planning. customer approval is obtained for the change. pre-launch and production processes.3.

including a full dimensional inspection of the tooling and the monitoring of timely completion. repair (TR03. storage and recovery (TR03) of production tooling.6 Management of Production Tooling As applicable. the Quality Planning Team is involved in the planning of changes to tooling and fixtures. 2. review and approval of production tooling and fixtures. including engineering change level. Customer-supplied tooling is inspected and approved by Manufacturing. Toolroom and Quality Assurance. these changes are passed on to the Toolroom for implementation. construction. TR04). the departments of Manufacturing. As required. The Mexico Toolroom is responsible for preventive maintenance (TR03). the inventory turnover rate is calculated and corrective action is taken in case that the turnover rate is below the established minimum.: 37 of 46 Revision: 0 Issued: 2004/Feb/02 Quality Manual and a predictive maintenance analysis that assists in the review of preventive maintenance cycles. Tool modification and revision to documentation are coordinated between Engineering and the Toolroom. Quarterly. Established controls are followed to effectively coordinate all activities. a tracking and follow-up system is put in place by Engineering or Manufacturing. As required.5. maintenance methods and inventory of replacement parts. The Engineering department is responsible for design changes of tooling and fixtures. 2.Page No. .3. • • • • • • • In the event that design or construction is contracted to outside sources (EG04). The status or availability of tooling and fixtures is clearly identified (TR03).7 Production Scheduling Manufacturing is responsible for production scheduling. Equipment and tooling and gauging that are kept in Manufacturing are packaged and preserved according to manufacturer’s guidelines and recommendations. • The Toolroom is responsible for the construction of tooling and fixtures (TR01). Engineering. The production scheduling of custom-made parts is forecasted.3. Toolroom and Quality Assurance are responsible for the design. Manufacturing establishes programs for changes of perishable tools in production. The set-up of tooling and equipment is the responsibility of Manufacturing (MF07).5.

QA02. Using the implemented computerized system in Manufacturing. 2. QA04. and re-validation in case that expected results are not achieved.5. product and material during production.5.5 Identification of Traceability Identification and traceability Designated personnel in Quality Assurance. Manufacturing and Quality Assurance. This includes constituent parts of a product. including . the Management Representative issues quarterly statistics (QS04) which are analyzed by the heads of Engineering.5. and product and material in storage with the product identification and inspection status (MF06. Corrective or preventive action is taken as required. . 2. regarding their ability to achieve planned results. approval and requirements of these processes. packaging. The quality planning team establishes procedures for the review. Manufacturing and Warehouse identify incoming product and material. shipping and production.: 38 of 46 Revision: 0 Issued: 2004/Feb/02 Quality Manual 2. Attention is given to special processes where the results cannot be verified through measurement or testing. 2.as applicable: criteria for review and approval. required records. sensors manufactured by OPTEK are traceable by date codes. handling and storage.8 Feedback of Information Based on customer feedback provided by Sales.4 Validation of Processes Validation of processes for production Where the resulting process output cannot be verified through monitoring or measurement. approval of equipment and qualified personnel. storage and protection of product and materials during receiving.Page No. Sales. the use of methods and procedures. the Quality Planning Team validates production processes with the assistance of Manufacturing and Engineering. handling.5.6 Preservation 2. Temperature sensitive products and materials are stored in the temperaturecontrolled room.3.6. where deficiencies become apparent when the product is already in use. WH02).1 Preservation of Product It is the responsibility of Manufacturing and the Warehouse to ensure the proper identification. QA03.5.

7.5. the processes of the Quality Management System are analyzed by the Management Representative and responsible Department Heads regarding their effectiveness. As required. 2. The inventory turnover rate is periodically reviewed and corrective action is taken in the event that the turnover rate is below the established minimum. maintainability and availability. reliability. to correct nonconformities or to improve the operational effectiveness and efficiency of the processes of the Quality Management System. Manufacturing ensures that processes are implemented according to control plans and other applicable procedures or documents in order to ensure that process capability and process performance is maintained according to customer part approval process requirements. using the computerized production scheduling system.2 Storage and Inventory During periodic cycle counts. .5.5. When processing shipping orders (217-0014-001). the quality planning team arranges for the monitoring of new and modified manufacturing processes (EG01).: 39 of 46 Revision: 0 Issued: 2004/Feb/02 Quality Manual 2. including adherence to specified measurement techniques. and based on statistics of operational performance (QS04) and the achievement of quality objectives.Page No.2 Monitoring and Measurement of Manufacturing Processes To verify process capability and provide additional input for process control. minimum inventory levels and appropriate stock rotation (FIFO) of product and raw materials. corrective action is implemented to achieve planned results and product conformity. 2. the condition of materials and products in the warehouse is verified to ensure that any deterioration or damage is detected and recorded. acceptance criteria and reaction plans.7 Monitoring & Measuring of Processes 2.7. the staff in Warehousing ensures that FIFO is applied. Manufacturing is responsible for keeping established inventory levels of finished product.5. The MRP-system in Manufacturing is used to ensure optimized inventory turns over time.1 Monitoring and Measurement of Processes During Quality Management System Planning. Control plans and process flow diagrams are implemented. and that required corrective action is taken. verification and maintenance as well as objectives for manufacturing process capability. Results are documented and include instructions for production processes. sampling plans.6.

the applicable reaction plan is followed. In the event that purchased product is released for urgent production prior to inspection and acceptance by Quality Assurance. Corrective action is taken as per established procedure QS10 in order to restore required process capability and product quality.8. Records of these inspection results are verified.Page No. If required. As required. whether the product was . If identified characteristics on the control plan become unstable or non-capable.5. The warehouse staff performs a visual inspection of outgoing product to ensure that the product and packaging is in good condition and that marking and labeling requirements are met. defined reaction plans are followed. these reaction plans include containment of produced parts or products and 100% inspection. reviewed and maintained. these corrective action plans are reviewed with and approved by the customer. in-process inspection (QA03) and final inspection (QA04) of product and materials. Important events that are occurring during production. These inspection records document acceptance criteria. Product is not released until all specified requirements have been met. Quality Assurance selects accredited laboratories for certain inspection or testing activities.1 Monitoring and Measurement of Product It is the responsibility of Quality Assurance to establish and maintain procedures and inspection reports for receiving inspection (QA02).: 40 of 46 Revision: 0 Issued: 2004/Feb/02 Quality Manual It is the responsibility of Manufacturing to monitor process capability and to ensure that process capability and performance is according to applicable control plans. 2. Inspection results are recorded and records are maintained. such as down times are recorded. Product that does not meet specified requirements is rejected and quarantined per established documented procedure. In case of nonconformity of processes. If appropriate. Effective dates of process changes are documented by Manufacturing. inspection results.8 Monitoring & Measuring of Product 2. unless otherwise approved by an authorized function . the product is recorded and controlled in order to permit recall and replacement in case of nonconformity of the product.5.and where applicable by the customer.

including the customer’s release authorization. Where applicable. Detailed instructions for required rework are available to operators in work instructions.2 Dimensional Inspection and Functional Testing At least once every twelve months.1 Control of Nonconforming Product and Reworked Product Nonconforming product and product without proper identification is quarantined and controlled according to the documented procedure QA01. Functions concerned are notified. Records of nonconforming product. Qualified personnel in Manufacturing process rework Orders.: 41 of 46 Revision: 0 Issued: 2004/Feb/02 Quality Manual accepted or rejected and the inspection authority responsible for the product release. Manufacturing ensures that the required concession is received prior to initiation of the repair. or as otherwise specified by the customer.9. The nonconformity of the product is verified and confirmed by Quality Assurance and verification results and recommended disposition or action are recorded. Engineering or Sales review and authorizes the release of quarantined product for its final disposition. Manufacturing.Page No. the Engineering department with Manufacturing & Quality Assurance and Sales department analyze the impact .5.9 Control of Nonconforming Product 2. Quality Assurance performs a dimensional inspection and functional verification (QA12) for each product specified in control plans. Manufacturing ensures that the reworked product is identified with the actual condition of the product.5. 2. actions taken and concessions obtained are maintained in First Time Quality reports. Quality Assurance.8. or after its use in production or service.5. Reworked product is re-inspected by Quality Assurance. including the type of nonconformity. As appropriate and required. 2. Results are available to the customer upon request. In the event that nonconforming product is detected after the product was shipped to the customer. the customer is notified by Sales of the proposed use or repair of nonconforming product. according to the following options: • rework to meet specified requirements • accept with or without repair by concession • re-grade for alternative applications • reject or scrap If the acceptance with or without repair requires the concession of the customer or the approval or permit of a regulatory body or other authority.

or purchased product. . the customer is informed and the nonconforming product is recalled. or that temporary change to product and processes is required. As required. As required. Nonconforming purchased product and material is returned to the supplier with a Supplier Corrective Action Request (Process Map: SCAR Process) issued by Supplier Quality Assurance (QA11). the request for temporary change or deviation is submitted to Engineering for approval (EG01). customer production part approval is obtained (QA10).: 42 of 46 Revision: 0 Issued: 2004/Feb/02 Quality Manual of the nonconformity and take appropriate action.5. Products manufactured and shipped on customer authorization are identified as such on each packaging unit or container. or manufacturing processes are different from the product or process approved by the customer. Manufacturing keeps records of expiration dates and quantities of authorized deviations and ensures that normal production activities are re-instated after expiration of engineering deviations.9.Page No.2 Customer Waiver In the event that manufactured product. 2.

first issue .: 43 of 46 Revision: 0 Issued: 2004/Feb/02 Quality Manual Approvals & Revision History OPTEK Quality Manual .revision control Page No. All (1-45) Reference Revision Date Description of Change Initials 1st issue 0 2004/Mar/11 No change .Page No.

4.1 5 5.2.1.4.1 6.1 5.2 1.2 1.5.7 1.9.1 5.: 44 of 46 Revision: 0 Issued: 2004/Feb/02 Quality Manual Appendix A: ISO/TS Cross Reference to this Manual ISO/TS16949 Clause # Description OPTEK Quality Manual Paragraph 4 4.1.2.3.2.4.1 5.1 5.2 7 7.1 2.2 1.2.1.1. Authority & Communication Responsibility for Quality Management Representative Customer Representative Internal Communication Management Review Resource Management Provision of Resources Human Resources Competence.10 1.1.4.2.6 6 6.4.2.2 2.1 1.3.2.1.5.1.1.5.4 4.1 6.1.1 6.4 1.4.3 6.5 1.2.9.2.1 .2 6.1.9 1.4.1 2.4 6.2.2 2.5.4.1.1 1.2 6.3 5.1.2 2.1.1.Page No.1 7.6 1.5 2.5.2 5.2.1.3 1.1 5.5.3. awareness & training Product design skills Training Training on the job Employee motivation & empowerment Infrastructure Plant.1 4.4.8 1.9.1.2 4.1 1.1 2.2.7 1.2.3 4.2.Supplemental QMS Planning Responsibility.5.4.supplemental 1.1 5.2.2 5.6 1.3.1.1 6.9.1 Quality Management System QMS General Requirements QMS General Requirements Quality Manual Scope Document Control Engineering Specifications Records Control Records Retention Management Responsibility Management Commitment Process efficiency Customer Focus Quality Policy Quality Objectives Quality Objectives .4.2 6.2.1 5.1.2.1 2.1 1.3 6.1.2.3 5.1 4.9.2.1.2.3 1.5.2a 4.5.2.10.4 6.1 1.2.2 5.1.3 1.4 1.1. facility & equipment planning Contingency plans Work Environment Personnel safety to achieve product quality Cleanliness of premises Product Realization Planning of Product Realization Planning of product realization .2.1.2 1.4.1 About this Manual Scope 2.2.1 2.1 4.2 1.1 6.1.1.2.1.1.

1 1.5.4 2.2 7.6 1.3 1.3 8.7 2.8 2.5.5.5.1 8.4 8.1 2.1 7.4 1.1.Page No.2.1 7.2 2.2 8.1.1.5.: 45 of 46 Revision: 0 Issued: 2004/Feb/02 Quality Manual Acceptance criteria Confidentiality Change Control Determination of Requirements Customer designated special characteristics Review of Requirements related to the product Review of Requirements related to the product . Organization manufacturing feasibility Customer Communication Design & Development Purchasing Control of Production Provision Validation of Processes Identification & Traceability Customer Property Preservation Control of Monitoring & Measurement Devices Measurement.10.5 1.1.3 1.2 .1.4.1 2.3 7.2.2 7.4 7.5.1.1 2.4.6 8 8.3 7.2.Suppl.2.3 7.10.3 2.5.2 7.2.4 8.2 2.2.5.1.1.5.3 2.6 2.1 7.4 7.2 1.4 7.9 1.5.1.4 2.2 1.3 7.2 2.5.2.1.5.5. Analysis & Improvement Measurement Analysis & Improvement: General Customer Satisfaction Internal Auditing Monitoring & Measuring of Processes Monitoring & Measuring of Product Control of Nonconforming Product Analysis of Data Continual Improvement Corrective Action Preventive Action 1.2 8.5 7.1 2.1 7.4 7.2.1.2.5 2.2.3 8.5 8.2.5.2 7.2.1 8.3 1.10.4.3.2.2.5.3.2.1 2.5.2.2.1.

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